Efficacy and safety assessment of traditional Chinese patent medicine for dyslipidemia: a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis.
Yini Fang, Haoran Wu, Xue Liang, Tianxing Li, Ruiting Jia, Yang Dong, Yanfei Zheng, Qi Wang, Lingru Li
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引用次数: 0
Abstract
Background: The overall prevalence of dyslipidemia continues to increase, which poses a significant risk for coronary artery disease. Some patients with dyslipidemia do not respond to or benefit from conventional lipid-lowering therapy, which warrants the need for alternative and complementary therapies. Chinese patent medicine (CPM) has shown great potential in the treatment of dyslipidemia, but its clinical value needs to be further explored. This study aims to systematically evaluate the efficacy and safety of CPM in treating dyslipidemia.
Methods: This study was registered in INPLASY as INPLASY202330090. The randomized controlled trials included in this study were published in January 2013 to March 2023 and retrieved from the Web of Science, PubMed, Embase, Cochrane Library, SinoMed, China National Knowledge Internet, WanFang, and VIP. The bias risk in the study was independently evaluated by two reviewers using the Cochrane Randomized Trial Bias Risk Tool (RoB 2) Review Manager 5.4 software was used for the overall effect analysis and subgroup analysis of four blood lipids, and the trial sequential analysis (TSA) was conducted to check the results.
Results: A total of 69 studies were included, involving 6,993 participants. The methodological quality was in the middle level. Meta-analysis showed that CPM markedly improved the levels of total cholesterol (TC) [mean difference (MD) =-0.54 mmol/L; 95% confidence interval (CI): -0.71 to -0.37; P<0.001], triglyceride (TG) (MD =-0.43 mmol/L; 95% CI: -0.53 to -0.33; P<0.001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.40 mmol/L; 95% CI: -0.50 to -0.30; P<0.001) and increased levels of high-density lipoprotein cholesterol (HDL-C) (MD =0.23 mmol/L; 95% CI: 0.18 to 0.27; P<0.001), in patients with dyslipidemia. Though CPM did not differ significantly from statins when used alone, it could improve lipid profile better in all cases when used in combination with statins and with drugs used for comorbidities or co-morbidities. Subgroup analysis found that the efficacy of pill formulations was superior to other formulations, and CPM showed better lipid-lowering response in the context of comorbidity. The TSA confirmed the robustness of the analysis of the LDL-C level. No significant difference was observed in the incidence of adverse events between the treatment group and the control group [risk ratio (RR) =0.89; 95% CI: 0.69-1.16; P=0.40].
Conclusions: CPM can yield superior therapeutic effects in ameliorating dyslipidemia without exacerbating adverse effects as an alternative and complementary therapy. In addition, the therapeutic effect can be improved by emphasizing pill formulation and strengthening the standardization of syndromes.
期刊介绍:
The journal ''Cardiovascular Diagnosis and Therapy'' (Print ISSN: 2223-3652; Online ISSN: 2223-3660) accepts basic and clinical science submissions related to Cardiovascular Medicine and Surgery. The mission of the journal is the rapid exchange of scientific information between clinicians and scientists worldwide. To reach this goal, the journal will focus on novel media, using a web-based, digital format in addition to traditional print-version. This includes on-line submission, review, publication, and distribution. The digital format will also allow submission of extensive supporting visual material, both images and video. The website www.thecdt.org will serve as the central hub and also allow posting of comments and on-line discussion. The web-site of the journal will be linked to a number of international web-sites (e.g. www.dxy.cn), which will significantly expand the distribution of its contents.